Requirements
In a regulated environment (DIN/ISO/ICH) method validation and documentation demands a very careful planning of the validation range, the application of accepted statistical procedures and the detailed documentation of validation results.
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Solution
VALIDAT simplifies the time consuming process of method validation as required by DIN/ISO/ICH, saving time and reducing costs. Templates, wizards and powerful reporting tools help you creating high quality method validation reports efficiently. VALIDAT supports standalone and network installations for the corporate wide use. On standalone systems, validations are stored in network aware database files. Microsoft and ORACLE SQL-Servers are supported on client/server-installations. Data can either be manually imported or transferred via the import wizard. Interfaces for LIMS- and CDS-systems are also available, offering easy access to sequences and work lists and automatic result data transfer to VALIDAT.
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Functional Range
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Supported Guidelines and Regulations
ICH Q1A, Q2A/Q2B,
DIN 53804, 32645, 55303, 55350, 38402, 5725,
ISO 3534-2, DIN 17025; optional: bioassay analysis according to Ph. Eur. 4, Chap. 5
- randomized assay design
- Parallel-line model
- tests on normal distribution and variance homogeneity
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Checkpoints
Precision, accuracy, linearity, calibration function, intermediate precision/ring experiment, robustness, lab capability, selectivity, limit of detection and determination, stability
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Statistical Tests
t-test, F-test, Bartlett-test, Wilcoxon-test, Chi-square-test, tests on robustness, outlier (Dixon, Grubbs), linearity (Mandel), homogeneity, selectivity etc.; levels of significance can be selected from 1% or 5% one- or two-sided depending on context.
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Reporting
Efficient reporting with integrated text processing, selectable decimal precision in output, selectable output range, table of contents, header, footer, signature line, timestamp, user context etc.;
checkpoint- components- and overall-reports.
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Graphics
Precision graphics, linearity graphics including residual- and confident interval, parallelism graphics, box- and whisker-plots,
configurable graphics (colours, symbols, structure), selectable scaling, zoom
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Language Support
Report creation in German and English (can be changed during runtime).
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Import & Export
Text formats: ASCII, HTML, RTF, Word 97-2003, PDF
Graphic formats: BMP, JPG, WMF, EMF
Clipboard
Drag-und-Drop
direct connection to MS-Office via report
import wizard for summary reports of current data systems
Interfaces for CDS and LIMS, i.e. LABS/Q and Varian Galaxie
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21 CFR Part 11
Hierarchical user management,
audit trail (validation, program, default settings) with full context;
checksum secured data transfer, electronic signatures, revision filing (see DMS).
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Document Management System (DMS)
Revision filing of validation data, reports, methods and attachments; time stamps, user specified reason, labels, comments; fast queries through a powerful search dialog; filing.
Optional workflow via DMS-Viewer
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Data Bases Supported
Microsoft Jet 4.0 (local)
Microsoft SQL Server 2000
ORACLE SQL Server 8.1.7, 9.2 and 10.1.
as well as
support of Windows Terminal Server and Citrix Server
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For further information please read the following PDF file:  |
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